Effect of Unani medicine Khamira Gawzaban Sada in Zu‘f al-DimÄgh (Cerebro-asthenia)

Phase 2

Recruiting

• Conditions: Other degenerative diseases of nervous system, not elsewhere classified, Zu‘f al-DimÄgh (Cerebro-asthenia),

• Registration Number: CTRI/2018/09/015692
• Lead Sponsor: Central Council for Research in Unani Medicine

Brief Summary

This study is designed as a multicentric open trial in patients with **Zu‘f al-DimÄgh (Cerebro-asthenia)****)** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically at every 2 weeks,i.e., at days 14, 28, and 42 of treatment.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be one week. . Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

Composition of*Khamira Gawzaban Sada*

| | | | |

| --- | --- | --- | --- |

|**S. No.**

**Ingredients**

**Botanical/Zoological/Chemical Name**

**Quantity**

|1.

Abresham Muqarraz

*Bombyx mori* L. (Cocoon)

25 g

|2.

Badranjboya

*Melissa parviflora* Benth.

175 g

|3.

Berg Gawzaban

*Borago officinalis* L.

150 g

|4.

Burada Sandal Safaid

*Santalum album* Linn.

125 g

|5.

Behman Surkh (Neem Kofta)

*Salvia haemetodes* L.

100 g

|6.

Tukhm Balangoo

*Lallemantia royleana* Benth.

125 g

|7.

Tudri Surkh

*Cheiranthus cheiri* Linn.

50 g

|8.

Kishneez Khushk

*Coriandrum sativum* Linn.

150 g

|9.

Gul-e-Khatmi

*Althaea officinalis* L.

50 g

|10.

Gul-e-Gawzaban

*Borago officinalis* L.

50 g

|11.

Shakar Safaid

Sugar (*Saccharum officinale*)

10 kg

|12.

Sat Leemu

*Citrus limon* (L.) Burm. f.

20 g

|13.

Natroon Banjawi

Sodium Benzoate

6 g

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-15
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• The patients fulfilling the following criteria will be included in this study: 1.
• Patients of any sex in the age group 19-70 years 2.
• Patients of Zu‘f al-DimÄgh (Cerebro-asthenia) having: Subjective complaints of cognitive impairment MMSE score of 10-23 representing mild to moderate cognitive impairment.

Exclusion Criteria

1.Clinical presentation and/or history of any significant organic neurological diseases including space occupying lesions, stroke, head injury, seizure, and mental retardation 2.Patients with impairment of speech, hearing and vision, which can impede the interview for MMSE and QOL assessment 3.Known cases of hypothyroidism or hyperthyroidism 4.Vitamin B12 deficiency 5.Patients on Psychotropic Drugs 6.Clinical presentation and/or history of a chronic disease that requires long-term treatment, e.g., DM, tuberculosis, HIV infection, syphilis, CVD, pulmonary disease, CKD, chronic liver disease, or any other serious and/or unstable medical condition that, in the opinion of the investigator, could expose the patients to undue risk of a significant adverse event or interfere with assessment of safety or efficacy during the course of the trial 7.Pregnant and lactating women 8.H/o Addiction (alcohol, drugs) 9.H/o Hypersensitivity to the study drug or any of its ingredients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Zu‘f al-DimÄgh (Cerebro-asthenia)	6 weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	at baseline and at the end of treatment

Trial Locations

Locations (2)

Central Research Institute of Unani Medicine (CRIUM); 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Regional Research Institute of Unani Medicine; 🇮🇳 Mumbai, MAHARASHTRA, India

Central Research Institute of Unani Medicine (CRIUM)

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Hina Rehman

Principal investigator

8297173005

hinarehman06@gmail.com